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A Retrospective Study on the Predictive Value of Preoperative Bilirubin and Enzymatic Indices for Additional Non-Sentinel Lymph Node Metastasis in Breast Cancer Patients with Positive Sentinel Lymph Nodes

A Retrospective Study on the Predictive Value of Preoperative Bilirubin and Enzymatic Indices for Additional Non-Sentinel Lymph Node Metastasis in Breast Cancer Patients with Positive Sentinel Lymph Nodes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128906
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Gold Standard:Past clinical treatment records. Pathology report records.
Index test:Preoperative Bilirubin and Enzymatic Indices

Sponsors

The First Hospital Of Jiaxing
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Female; 2.Age >= 18 years; 3.Pathologically confirmed at our institution as primary invasive breast cancer between January 2019 and May 2026. 4.Patients who underwent breast cancer surgery and SLNB at this institution, in whom the SLN demonstrated micrometastases or macrometastases, and who subsequently underwent ALND with definitive pathological results. 5.It enables the determination of whether additional positive non-sentinel lymph nodes are present in an ALND specimen. 6.Preoperatively, blood biochemical parameters available for calculating the BEI were present, including TBIL, ALT, AST, and LDH. 7.The clinical data satisfy the primary analytical requirements of this study.

Exclusion criteria

Exclusion criteria: 1.Patients undergoing surgery following neoadjuvant therapy; 2.Pure Ductal Carcinoma In Situ (DCIS) or DCIS with Microinvasion; 3.Cases with indeterminate outcome variables or in whom ALND was not performed, precluding determination of additional NSLNM status. 4.Patients lacking key preoperative blood parameters, rendering the calculation of primary study endpoints impossible. 5.Preoperative conditions that may significantly affect hematological, inflammatory, coagulation, or biochemical parameters—such as acute infection or fever, active autoimmune disease, hematological disorders, or recent major trauma, surgery, or thrombotic events—are present. 6.Severe hepatic and renal function abnormalities (ALT or AST exceeding the upper limit of normal by more than 2-fold; TBIL exceeding the upper limit of normal by more than 1.5-fold; or LDH significantly elevated above the upper limit of normal). 7.Individuals undergoing long-term use of systemic corticosteroids, immunosuppressants, or therapeutic-dose anticoagulants, where the investigator determines that such use is likely to significantly affect relevant parameters. 8.Other circumstances deemed unsuitable for inclusion in the analysis by the researchers.

Design outcomes

Primary

MeasureTime frame
Area under the receiver operating characteristic curve (AUC) for predicting additional NSLNM after ALND using BEI;

Secondary

MeasureTime frame
BEI Sensitivity;BEI Specificity;

Countries

China

Contacts

Public ContactXiang Lu

The First Hospital Of Jiaxing

netzerg@126.com+86 573 82082937

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026